Before agreeing to participate in this study, it is important that you read and understand the following explanation of the proposed study procedures. The following information describes the purpose, procedures, benefits, discomforts, risks and precautions associated with this study. It also describes your right to refuse to participate or withdraw from the study at any time. In order to decide whether you wish to participate in this research study, you should understand enough about its risks and benefits to be able to make an informed decision. This is known as the informed consent process. Please contact the study staff at the numbers provided below to explain any words you donât understand before agreeing to take part. Make sure all your questions have been answered to your satisfaction before taking part.

Study and Purpose

This project is an opportunity to study women currently participating in our Risk Factor Analysis of Hereditary Breast and Ovarian Cancer Study. It is critical to understand the impact of preventive surgery, a cancer diagnosis or other factors on cognition and memory. We will study how various factors including medications or lifestyle may have a beneficial or negative impact on memory and attention. This is the first internet-based observational study across North America focused exclusively on cognition and memory among high risk women and will allow us to study cognitive impairments in this particular population.

Procedures

You received an email invitation from the study coordinator to participate in this Risk Factor Analysis of Hereditary Breast and Ovarian Cancer Sub-study. If you choose to participate in this study, please read and complete this online form in order to provide written electronic consent. You are also being asked to complete the Online Brain Health Assessment referred to as Cogniciti (/cogniciti.com/Home/ResearchersPage), which is a rapid, reliable and freely available tool developed by experts in the field to learn about memory and attention. This assessment will require 15-20 minutes of your time. Following the collection of baseline data, the cognition assessment will be entered into a database using the unique study identification code provided to each participant and the data will be used for statistical analysis.

Benefits

Upon completion of the survey, you will receive a $20 (CAD) Starbucks gift card by email or mail to thank you for your participation. Additionally, if you are between the ages of 40-79, you will receive a personalized report on cognition and memory health that you can keep or share with your physician.

Risks

There are no risks associated with your participation in this study.

Confidentiality

We will respect your privacy. Any of your personal information (information about you and your health that identifies you as an individual) collected or obtained, whether you choose to participate or not, will be kept confidential and protected to the fullest extent of the law. All personal information collected will be kept in a secure location. The study staff and the WCH Research Ethics Board may look at your personal information for purposes associated with the study. The mentioned authorized personnel may view your records only under the supervision of the Principal Investigator and will be obligated to protect your privacy and not disclose your personal information. None of your personal information will be given to anyone without your permission unless required by law. The data produced from this study will be stored in a secure location. Only members of the research team will have access to the data. This could include external research team members.

Participation

Your participation in this study is voluntary. You can choose not to participate or you may withdraw at any time without affecting your medical care. Should you wish to withdraw from this study, you may do so by closing the internet browser window and no further data will be collected. Should you wish to withdraw, you have the right to withdraw your data from the study until the data has been pooled. After this date, it is possible that some form of research dissemination will have already occurred and it may not be possible to withdraw your data.

Questions

If you have any general questions about the study, please call the doctor in charge of this study, Dr. Joanne Kotsopoulos at (416) 351-3732 x2126. You may also call the study genetic counsellor, Dawn Lee at (416) 323-6400 x 2725. If you have any questions about your rights as a research participant, please call Dr. Nancy Walton, Chair of Womenâs College Hospital Research Ethics Board at (416)351-3732 ext. 2325. This person is not involved with the research project in any way and calling will not affect your participation in the study.

Consent

I confirm that:

I have no questions about this research study

I understand the requirements of participating in this research study

I understand the risks and benefits, if any, of participating in this research study

I understand the alternatives to participating in this research study

I understand my rights as a research participant

I have read each page of this form

I authorize access to my personal health information, medical record, and research study data as explained in this form

I have agreed, or agree to allow the person I am responsible for, to participate in this research study

I understand that my family doctor may be informed of my participation in this research study